Loxapine - Generic Drug Details
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What are the generic drug sources for loxapine and what is the scope of patent protection?
Loxapine
is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Loxapine has two hundred and twenty-seven patent family members in twenty-one countries.
There are eight drug master file entries for loxapine. One supplier is listed for this compound.
Summary for loxapine
| International Patents: | 227 |
| US Patents: | 7 |
| Tradenames: | 5 |
| Applicants: | 7 |
| NDAs: | 11 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 25 |
| Patent Applications: | 7,017 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for loxapine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for loxapine |
| What excipients (inactive ingredients) are in loxapine? | loxapine excipients list |
| DailyMed Link: | loxapine at DailyMed |
Recent Clinical Trials for loxapine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| Lariboisière-Saint Louis clinical research unit | Phase 3 |
| Lee's Pharmaceutical Limited | Phase 3 |
Medical Subject Heading (MeSH) Categories for loxapine
Anatomical Therapeutic Chemical (ATC) Classes for loxapine
US Patents and Regulatory Information for loxapine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elite Labs Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076868-004 | Aug 4, 2005 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva Branded Pharm | LOXITANE | loxapine succinate | CAPSULE;ORAL | 017525-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for loxapine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for loxapine
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Ferrer Internacional S.A. | Adasuve | loxapine | EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. |
Authorised | no | no | no | 2013-02-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for loxapine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2370395 | ⤷ Try a Trial | |
| Poland | 373836 | Sposób tworzenia aerozolu do inhalacyjnego podawania leku (METHOD OF FORMING AN AEROSOL FOR INHALATION DELIVERY) | ⤷ Try a Trial |
| European Patent Office | 1455875 | SUBSTRATS A CELLULES OUVERTES POUR ADMINISTRATION DE MEDICAMENTS (OPEN-CELLED SUBSTRATES FOR DRUG DELIVERY) | ⤷ Try a Trial |
| Japan | 2006514633 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for loxapine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | 300609 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | CR 2013 00046 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | SPC/GB13/055 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220 |
| 1389098 | CA 2013 00046 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
